- Patient characteristics are consistent with other DLB studies -
PURCHASE, N.Y., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented participant baseline characteristics in the Phase 2 ‘SHIMMER’ study of mild-to-moderate dementia with Lewy bodies (DLB). The poster is being presented at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference being held October 29 – November 1, 2024 in Madrid, Spain and is available on Cognition’s website.
“Looking at the mean scores, participants who entered our DLB study had mild-to-moderate levels of cognitive impairment; the severity of their fluctuations in attention were consistent with a clinical diagnosis of DLB; and most participants had mild movement impairment,” explained Anthony Caggiano, M.D., Ph.D., Cognition’s CMO and head of R&D.
Baseline characteristics of the 130 participants enrolled in the study, as described in the poster:
Mean Age
72.8 years
Sex
81.5% male
Race
91.5% white
Mean mini-mental state examination (MMSE) score
24.0
Mean Montreal Cognitive Assessment (MoCA) score
18.4
Mean Clinician Assessment of Fluctuation (CAF) score
5.9
Mean Epworth Sleepiness Scale (ESS) score
8.4
Mean MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score
27.7
Mean Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score
62.5
“DLB is one of the most common forms of dementia and a complex neurological condition. Symptoms include cognitive, motor, psychological and behavioral impairment that change over time as the disease progresses,” stated Lisa Ricciardi, Cognition’s president and CEO. “These characteristics are similar to participant demographics from other signal-finding studies in DLB. We look forward to reading out the results of our study later this year.”
CTAD Poster Details:
Title:
SHIMMER: Baseline Data and Early Lessons from the Ongoing Phase 2 Signal-finding Study of CT1812 in Mild-to-Moderate Dementia with Lewy Bodies (DLB)
Authors:
Galvin JE, Tolea MI, Iaci JF, Devins T, Hamby ME, Grundman M, Caggiano AO
Session:
Clinical Trials – Methodology: October 29-30, 2024
About Dementia with Lewy Bodies (DLB) Dementia with Lewy bodies is the second most common form of dementia, affecting an estimated 1.4 million Americans. The disease is believed to be caused by a buildup of the protein α-synuclein, which aggregates in Lewy bodies, which are found within brain neurons. DLB is referred to as a “whole-body” disease, as it disrupts biological processes affecting autonomic, digestive, cognitive, and motor systems. Varied initial symptoms may include day-to-day fluctuations in alertness level, hallucinations, delusions, movement disorders and REM sleep disorder (acting out dreams while sleeping). Only a few symptomatic treatments for DLB are approved and currently there are no disease-modifying therapeutics.
About the SHIMMER Study The SHIMMER study is a double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB. Participants were evenly randomized to receive either placebo or one of two oral once-daily doses of CT1812 (100 mg or 300 mg) for six months. Participants are assessed throughout the study using the Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE), which track cognitive performance; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; and the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism.
The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million and is being conducted in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). The SHIMMER study is being conducted at over 30 sites in the United States, many of which are LBDA centers of excellence.
About CT1812 CT1812 is an experimental orally delivered small molecule oligomer antagonist that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex. Preclinical and clinical data demonstrate that this binding results in the displacement of toxic Aβ oligomers. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer’s disease progression.
Participants are currently being recruited in the START study (NCT05531656) of CT1812 in adults with early Alzheimer’s disease; and the MAGNIFY study (NCT05893537) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration. Enrollment has completed in the SHIMMER study (NCT05225415) of CT1812 in adults with dementia with Lewy bodies.
About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com
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Contact Information: Cognition Therapeutics, Inc. info@cogrx.com
